Chen Hu, PhD, Associate Professor in the Department of Oncology at the Johns Hopkins University School of Medicine will be giving a presentation on  “Statistical Considerations of Biomarker-Driven Oncology Clinical Trials: Fundamentals, Controversies and Lessons Learned.” This presentation is entirely virtual, and will occur onSeptember 19, 2024, 12:00pm - 1:00pm via Zoom. Registration is required, and upon registration, attendees will received a confirmation email with information about joining the meeting.

ABSTRACT: In this precision oncology era, where molecular profiling at the individual patient level becomes increasingly accessible and affordable, more and more clinical trials are now driven by biomarkers, with an overarching objective to optimize and personalize disease management. As compared with the conventional clinical development paradigms, the choices of biomarker-driven clinical trial designs and analysis plans require additional considerations that are heavily dependent on the nature of biomarkers and the credential of biomarkers’ performance and clinical utility. In this talk we provide a concise overview of options, best practice and potential issues when designing and interpreting biomarker-driven oncology clinical trials. We focus on explaining the trial design and practical considerations and rationale of when to use which designs, as well as how to incorporate various adaptive design components to provide additional flexibility, enhance logistical efficiency, and optimize resource allocation. Lessons learned from real trials are also presented and discussed.